Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation

NCT ID: NCT07050212

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-03-01

Brief Summary

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By comparing the application effects of three drugs in pediatric preoperative sedation, this study explores the optimal medication regimen, aiming to provide safer, more effective, and more personalized medication options for pediatric preoperative sedation. Additionally, this research will also focus on the impact of these three drugs on postoperative agitation in children, offering valuable references for the overall management of pediatric surgical anesthesia.

Detailed Description

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Participants will be randomly allocated to three groups: remimazolam group(Group A), dexmedetomidine group(Group B), esketamine group(Group C). Before entering the operating room, an intravenous access is established. Under the accompaniment of a parent, one of the three drugs is administered intravenously.

Conditions

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Remimazolam Dexmedetomidine Esketamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Remimazolam group: Remimazolam is administered intravenously at a dose of 0.3 mg/kg

Remimazolam is administered intravenously at a dose of 0.3 mg/kg

Group Type EXPERIMENTAL

remimazolam group

Intervention Type DRUG

remimazolam is administered intravenously at a dose of 0.3 mg/kg

dexmedetomidine group: dexmedetomidine is administered intravenously at a dose of 1 μg/kg

dexmedetomidine is administered intravenously at a dose of 1 μg/kg

Group Type ACTIVE_COMPARATOR

dexmedetomidine group

Intervention Type DRUG

dexmedetomidine is administered intravenously at a dose of 1 μg/kg

esketamine group: esketamine is administered intravenously at a dose of 0.5 mg/kg

esketamine is administered intravenously at a dose of 0.5 mg/kg

Group Type ACTIVE_COMPARATOR

esketamine group

Intervention Type DRUG

esketamine is administered intravenously at a dose of 0.5 mg/kg

Interventions

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remimazolam group

remimazolam is administered intravenously at a dose of 0.3 mg/kg

Intervention Type DRUG

dexmedetomidine group

dexmedetomidine is administered intravenously at a dose of 1 μg/kg

Intervention Type DRUG

esketamine group

esketamine is administered intravenously at a dose of 0.5 mg/kg

Intervention Type DRUG

Other Intervention Names

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remimazolam dexmedetomidine esketamine

Eligibility Criteria

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Inclusion Criteria

1. Children aged 2 to 5 years old
2. the American Society of Anesthesiologists (ASA) physical status of Class I
3. scheduled for adenotonsillectomy under general anesthesia, will be included.

Exclusion Criteria

1. Abnormal lung function and respiratory system function
2. airway obstruction or deformity, history of mental illness
3. electrocardiogram indicating bradycardia
4. history of cardiac disease
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maternal and Child Health Hospital of Hubei Province

OTHER

Sponsor Role lead

Responsible Party

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Li Na

Deputy Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Na Li NaLi, MD

Role: PRINCIPAL_INVESTIGATOR

Maternal and Child Health Hospital of Hubei Province

Locations

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Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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NaLi, MD

Role: CONTACT

+862763490107

Other Identifiers

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MCHH_013

Identifier Type: -

Identifier Source: org_study_id

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